대한내시경복강경외과학회지 Vol. 14. No. 1, 011 복강경기구의재사용에대한임상적의의 원저 CHA의과학대학교분당차병원외과학교실, 1 진단검사의학과이이호ㆍ김종우ㆍ정철운ㆍ홍성근 1 The Clinical Significance of Reuse Disposable Instruments for Laparoscopic Surgery Yi Ho Lee, M.D., Jong Woo Kim, M.D., Chul Woon Chung, M.D., Seong Geun Hong, M.D. 1 Departments of Surgery and 1 Laboratory Medicine, CHA University Bundang CHA Hospital, Seongnam, Korea Purpose: Laparoscopic instruments have been remarkably developed through many trials. Various studies and experiments on laparoscopic instruments are underway in other countries. Laparoscopic surgery is also very actively applied in Korea. However, research on the use and safety of the instruments is stagnant. Furthermore, reuse of some disposable laparoscopic instruments is frequently observed, but there are only rare studies on the safety of this. Thus, we tried to provide study cases on the safety of repeated use of disposable laparoscopic instruments. Methods: To investigate the effectiveness of sterilization and a re-package procedure, we divided the laparoscopic instruments that are commonly used in our institution into 10 types. Among all the available instruments, 3 instruments were selected for the simulation experiment. Each instrument was sterilized using ethylene oxide gas or glutaraldehyde %, and then packaged. Then, each was observed grossly and microscopically under aseptic conditions and we looked for any remnant foreign body or contaminant. When remnant foreign body or contaminant was found, they were collected and separately cultured. Results: Residual contaminants were found in 15 instruments (46.9%) out of a total of 3 and microorganisms, including coagulase-negative staphylococcus and gammahemolytic streptococcus, were cultured from (9.38%), and each had different types of microorganisms. Conclusion: It is remarkable that the bacteria were cultured from recycled laparoscopic instruments after sterilization. The reuse of laparoscopic instruments might be cost-effective, but further studies on its safety are required. Moreover, careful inspection on the method of surgical instrument sterilization in each institution will be necessary. Key words: Laparoscopy, Laparoscopic instrument, Disposable instrument 중심단어 : 복강경수술, 복강경기구, 일회용기구 서 외과영역에서복강경수술은 Semm 1 이처음으로복강경하충수돌기절제술을시행한이래로많은시행착오를거쳐현재에는거의모든외과영역의수술을복강경으로시행하고있다. 복강경수술의일반화와더불어복강경기구또한수술의종류와수술의사의필요에따라많은발전과변화를거듭해왔으며, 국내또한모든외과영역의수술에서복강경수술이보편화되었고이와함께일회용복강경기구가널리보급되었다. 일찍이외국에서는 DesCoteaux 등 3,4 에의해서재사용복강경기구의경제정과안전성에대해다각도의연구와실험이진행되어보고된바있으며, 최근에는 trocar의경우거의일회용을사용하고폐기하지만일부복강경기구의경우에는여전히일회용복강경기구 론 통신저자 : 정철운, 경기도성남시분당구야탑동 361 우편번호 :463-71 차의과대학교분당차병원외과 Tel:031-780-550, Fax:031-780-559 E-mail:wehrwolf@cha.ac.kr 를재사용하고있는것이현실이다. 이논문은국내에서는외국에비해재사용기구에대한안전성을연구한사례가없기에이에대한자료를제공하고그임상적의미를살펴보고자하는데그목적이있다. 대상및방법 010년 5월부터 010년 10월까지차의과학대학교분당차병원외과에서복강경수술시일반적으로사용하는복강경기구를크게 10종으로나누어각각의그룹중에서임의로선정한 3개의기구를가지고실험하여조사하였다 (Table 1). 복강경기구는병원인증규정에합당하는수술실의복강경기구관리프로토콜에따라수술전, 수술중, 수술후에점검이시행되었다. 복강경기구의소독은 suction tube의경우에는 glutaraldehyde % 용액으로소독하여소독포로포장하였고그외의기구는 ethylene oxide gas로소독후비닐포장을시행하였다. 각그룹별로선정된기구들은복강경수술과동일한환경의수술실에서무균상태로육안과수술용현미경 (Zeiss MDU/S) 을이용하여이물질존재의여부, 17
18 대한내시경복강경외과학회지제 14 권제 1 호 011 Table 1. Disposable laparoscopic instruments Table 3. Debris observed on laparoscopic instruments Instruments No. (n=3) Instrument Site Type Harmonic scarpel Grasper Dissector Hook Scissor Veress needle Troca (5, 10, 1 mm) Suction handle Suction tube Endo clip Table. Classification of residual debris 6 (,, ) 4 8 s: A flat area of discoloration produced by foreign matter (eg, dried blood, biologic fluids) s: A small fragment of identifiable foreign matter (eg, dried blood, eschar from cautery) s: A small quantity of liquid appearing as a spherical mass (ie, residual water from the ultrasound bath not evaporated during the drying process) Harmonic scalpel 1 Harmonic scalpel Grasper 1 Grasper Dissector 1 Dissector Hook 1 Hook Scissor 1 Scissor Veress needle 1 Veress needle Trocar 1 Trocar Trocar 3 Trocar 4 Trocar 5 Trocar 6 Suction handle 1 Suction handle Suction handle 3 Suction handle 4 Suction tube 1 Suction tube Endo clip 1 Endo clip Endo clip 3 Endo clip 4 Endo clip 5 Endo clip 6 Endo clip 7 Endo clip 8 Potector Potector Plastic cover Rubber cover Rubber cover Troca hole Handle inner plate Tube Tube, handle inner plate Tube inner space Tube inner space (grease), greenish stain Fig. 1. in joint of dissector. 1) 오염도의관찰 결 과 오염정도, 기구의손상정도를확인하였다. 남은이물질과오염정도는 3가지로분류하였다 (Table ). 기구의이물질이나오염이발견된부분은세균배양용소독면봉이나작은조각형태로수집하여대조군인비사용 trocar 개의첨단부분과함께 thioglycollate broth와 blood agar에서 37 o C에서 48시간동안세균배양을실시하여그결과를확인하였다. 총 10종 3개의복강경기구를검사한결과총 8종 15개 (46.9%) 의기구에서이물질이발견되었다 (Fig. 1). 이물질은각각조각 (particle) 7개 (46.7%), 작은방울 (droplet) 3개 (0.0%), 얼룩 (stain) 이 5개 (33.4%) 였다. 주로수술시직접조직과맞닿는부분이나절제한조직이나오는부분그리고기구의관절부분을싸고있는부분에서관찰되었다 (Table 3). 그리고복강경기구를검사한결과일부기구에서반복적인사용으로인해기구손상이관찰되었고특히 suction handle의경우에는기구내부에서버튼과스프링사이에서윤활제가관찰되었다 (Fig. ).
이이호외 3 인 : 복강경기구의재사용에대한임상적의의 19 ) 세균배양이물질은발견되지않았지만재사용빈도수가높은 endo-clip 3개를포함하여총 18개 (56.3%) 의기구에서세균배양을실시하였다. 그결과 harmonic scalpel, hook, endoclip 에서각 1개씩총 3개의기구 (9.38%) 에서세균이배양되었다. 그중 harmonic scalpel과 hook에서는 coagulase negative staphylococcus가배양되었으며, endo clip에서는 gamma-hemolytic streptococcus가배양되었다 (Table 4). Fig.. (grease) in suction handle. 고 복강경수술은다양한영역에도입되어이제는전통적인고식적수술법을급속히, 그리고광범위하게대체해나가고있다. 외과영역의질환에대해서는 1987년에처음으로담낭절제술을시행한이래로술기의개발, 경험의축적, 기구의발달로인한수술의적응증이확대되어그범위를넓혀가고있다. 5 복강경기구가발달함에따라외국에서는일찍이일회용복강경기구의재사용에대해많은연구와실험을하여보고하였다. DesCoteaux 등 3 은엄격한가이드라인과주의깊은관찰아래서재사용기구를사용한다면비용측면에서효율적이기에일회용복강경기구를재사용할수있다고하였으며, Adler 등 6 은경제적효과를분석하면서복강경담낭절제술에서 9배이상의비용절감효과가있기때문에복강경기구를한번사용하고폐기하는것이다른명백한장점이없는한재사용해야한다고하였다. 그외에도많은연구에서일회용복강경기구의재사용은치료결과에영향을미치지않으면서비용절감효과가있다고보고하였다. 7,8 하지만일회용복강경기구의재사용에따른문제점에대한연구도활발하게진행되어왔다. DesCoteaux 등 4 은복강경수술후재사용을위해소독을시행한기구를검사하여 84.3% 에서잔류조직의발견을보고하였으며추후많은연구를통한보완을제시하였다. 이후다른연구에서일회용 찰 Table 4. Culture media and result Instrument Media Result Harmonic scalpel 1 Harmonic scalpel Grasper 1 Dissector 1 Dissector Hook 1 Hook Scissor 1 Scissor Trocar 3 Suction handle 1 Suction handle 3 Suction handle 4 Suction tube 1 Suction tube Endo clip 1 Endo clip Endo clip 5 Control 1 Control, Coagulase negative staphylococcus Coagulase negative staphylococcus Gamma-hemolytic streptococcus
0 대한내시경복강경외과학회지제 14 권제 1 호 011 복강경기구의재사용에따른합병증을조사한결과 1.8% 에서만상처감염을보고하였으며기구의오작동으로인한합병증은없다고보고하였다. 9 Roth 등 10 과 Heeg 등 11 은일회용복강경기구를소독하여재사용하는경우포장훼손, 기구의기능저하등여러가지요인으로인하여바이러스나세균증식의가능성이있으며환자에게위험할수있다고주장하였으며, Santos 등 1 은멸균전복강경기구를검사한결과 46.5% 의기구에서세균과곰팡이균이배양되었으나멸균후에는미생물이배양되지않으므로복강경기구의재사용의가능성과멸균소독의중요성을제시하였다. 그밖에도많은연구와실험에서일회용복강경기구를재사용하는데필요한가이드라인이발전되어왔다. 13-16 우리나라의경우 trocar와같은일회용복강경기구는더이상재사용하지않지만 endo-clip과같은경우에는수가와보험관련문제등으로재사용이불가피한현실이다. 기구의이러한일회용복강경기구의재사용을위해서는복강경기구의소독과관리가무엇보다도중요하다. 대부분의병원에서복강경기구는크게세척, 소독, 멸균의 3가지단계를거쳐재사용하게된다. 그중멸균은세균성미생물, 바이러스, 진균은물론포자까지도죽이는것으로외과적무균상태를유지하기위한가장완벽한방법이다. 멸균에대한정확한기준은세균배지에서미생물의성장이없는상태이어야하며이러한멸균은물리적또는화학적방법에의해얻어질수있다. 멸균법은크게고압증기멸균법, 건열멸균법, ethylene oxide gas 멸균법, 화학멸균법등으로나눌수있는데, 본원에서는 ethylene oxide gas 멸균법과화학멸균법중 glutaraldehyde % 용액을이용한방법을사용하고있다. ethylene oxide gas 멸균법은다른멸균법에비해시간은오래걸리지만열에의해멸균되지않거나구멍이없는물품에효과적이며화학멸균법중 glutaraldehyde % 용액의경우단시간내에모든형태의미생물에대한살균력이우수한것으로알려져있다. 본연구에서 48시간배양검사에서세균의증식발견된것에대해서는여러가지해석이있을수있다. Coagulase negative staphylococcus는의료기구와관련된기회감염증의원인균으로패혈증을일으키는원인균으로도알려져임상적으로의미가있다고생각되어지나의료인의손에서배양되는균종의하나이기도하므로실험과정에서의실험수행자나도구에의한오염의가능성도배제할수는없다. 17-19 그러나, 실험이수술실과동일한무균적손세척, 수술복입기, 장비준비및시료체취의과정으로이루어졌기때문에이러한가능성은희박하다고생각되어진다. Hogg와 Morrison 0 은구강외과적치료를위한수술도구를세척하여우리의실험과같이 ethylene oxide gas 멸균하였는데, 7시간배양후에표면이갈라진연마봉 (fissure bur) 에서는 100%, 표면이둥근연마봉 (round burr) 에서는 45% 에서세균증식이있는것을보고하였다. 이는재사용시미세하게남아있는조직이재생전의세척작업 을통해서완전히제거되지않고멸균과정에서도불완전한멸균이된다는것을의미한다. 본실험에서도전체재생기구의 46.9% 에서정도의차이는있으나오염이발견되었고대부분의오염이나이물질이일반적인재생기구세척방식으로는접근이불가능한기구깊숙한내면이나관절및틈새에서발견된것으로보아, 이러한곳에존재하던세균이비록재사용시에는임상적의미가없는콜로니를이룰지라도적절한환경에서배양할경우병원성콜로니로증식할가능성이있음을시사할수있다. 이와더불어중요한것이복강경기구의기능적점검이라고할수있다. 본실험을통해서재생기구의내부에는인체조직에서유래한오염뿐만이아니라기계의재사용으로인한마모로인한기계적오염과기능적결함도발견되었는데, 이는기구의용도에따라그정도가다를수있겠지만재사용의횟수가늘어남에따라오작동과기능저하가불가피하게됨을시사한다. 복강경기구의내부혹은외부의마모나오작동등은재생과정의세척을어렵게하고세균의정착지가될수있으며수술적조작의오류로인하여성공적이고안전한수술에부정적영향을줄수있다고보인다. 따라서수술전복강경기구를점검하고문제점발견시바로폐기하는것또한중요하다고볼수있다. 본원에서도이와같은과정을통해서복강경기구를관리소독을하고있지만실험결과균의배양은간과할수없는사항이다. 또한이것은본원뿐만아니라현재모든병원의소독체제에대한전반적인재고와문제점발견시수정이필요할것으로사료된다. 복강경기구를재사용하는것은경제적관점에서만유용하다고할수있는것은아니므로향후적어도일회용으로개발된복강경기구들은더이상재사용하지않는것이바람직하며, 이를위해국내보험기관도이를장려할수있는제도개선을마련할필요가있다. 또한환자에게미치는영향을생각해볼때그안정성에대한검증또한반드시이루어져야한다. 본연구는여전히이루어지고있는일회용복강경기구의재사용에대한전반적인재고와그안전성에대한검증의필요성을제기하는데그목적이있으며추후많은연구와실험을통해검증과보완이필요할것으로사료된다. 결론일반적으로완전멸균소독을하고재사용하는복강경기구에서세균이배양된사실은주목할만하다. 현실적으로일부복강경기구에서소독후재사용하는것은비용효율성으로불가피하지만그안정성과문제점에대해서는국내에서도추후에많은실험과연구를통해서검증이필요할것으로생각된다. 또한그에따른문제를방지하기위해서각병원에서수술기구의소독방법과확인절차의변화가필요할것으로생각된다.
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